GLAUCOMA DEVICE INSERTER
An inserter device is provided for use with a glaucoma drainage device including a tube having a proximal end and a distal end with a lumen extending from the proximal end to the distal end. The inserter device includes an elongate member having a distal end defining a stop surface, and a stylus extending beyond the distal end of the elongate member. The stylus is sized and configured to be received within the lumen of the glaucoma drainage device with the stop surface interfacing to and limiting proximal movement of the glaucoma drainage device. The stylus has a first length that extends beyond the stop surface that is less than a second length of a portion of the lumen of the tube of the glaucoma drainage device that extends beyond the stop surface. Systems and methods are also described and claimed.
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This application claims priority to U.S. Provisional Application 62/811,045, filed Feb. 27, 2019, the entire contents of which are incorporated herein by reference.
BACKGROUNDInnFocus, Inc. of Miami, Fla. has issued patents on glaucoma drainage implants (GDIs) (e.g., U.S. Pat. Nos. 7,431,709, 7,594,899, 7,837,644 and 9,101,444), which are herein incorporated by reference in their entireties. A typical GDI is shown in
The GDI (particularly the tube 1 and possibly the fin(s) 4 of the GDI) is typically made from a soft and flexible material such as poly(styrene-block-isobutylene-block-styrene) (SIBS) of Shore hardness less than 60 A. In embodiments, the GDI can be made from SIBS of Shore hardness in the range 30 A to 50 A, more preferably in the range 35 A to 45 A, and possibly with a Shore hardness of 40 A. In embodiments, the diameter of the lumen 5 of the tube 1 can range from 0.04 mm to 0.1 mm, more preferably in the range 60 μm to 80 μm and can be 70 μm. The outer diameter of the tube 1 can range from 0.2 mm to 0.8 mm and can be 0.35 mm in embodiments. In these embodiments, the soft material and size and the tube 1 on both sides of the fin(s) 4 renders the tube 1 very floppy and thus difficult to push through the needle tract under the limbus and into the anterior chamber.
Implanting the device is traditionally accomplished with forceps which are used to hold the GDI near its proximal tip and incrementally move the GDI through the pocket and needle tract and into the anterior chamber. Problems with forceps is that the GDI needs to be held very carefully so as not to inadvertently squeeze the lumen closed, which can take tens of minutes to spring back open. In addition, the GDI is very small and it can be dropped. Further, the surgeon needs to lift his/her eyes from the surgical microscope to accept the GDI from the scrub nurse which is non-optimum. Lastly, the GDI does not always pass through the needle tract due to obstruction of the needle tract by fibrous strands and the like. In short, implanting the GDI with forceps is clumsy and not optimum. There is a need for a quicker and more reliable method of handling and implanting the GDI.
SUMMARYThe present disclosure describes an inserter that is used to support a soft flexible GDI when packaged, sterilized and shipped as well as to facilitate implanting the GDI into the eye. It is contemplated that the GDI and inserter will be packaged as a glaucoma system or kit with the GDI supported by the stylus of the inserter as described herein.
In this disclosure, the term “proximal” refers to a position closer to the surgeon implanting the device, and “distal” refers to a position away from the surgeon implanting the device.
The present disclosure describes an inserter that enables a soft flexible GDI to be inserted into a needle tract (or tissue passageway) that leads to the anterior chamber of the eye with the distal end 2 of the GDI in the anterior chamber of the eye. The inserter includes a stylus that is located within and received by the lumen 5 of the GDI. The stylus functions to support and carry the GDI as the GDI is inserted into and through the needle tract. For the purpose of this disclosure, the stylus can be a wire, a guidewire, a stylet, a stiffener, and the like and for simplicity will simply be referred to as a stylus. Further, in order to fit into the lumen 5 of GDI, the maximal outer diameter of the stylus can be smaller than the inner diameter (or lumen) of the GDI, which can be 60 to 80 μm in embodiments. Examples of materials that can comprise the stylus are stainless steel, cobalt-chromium-nickel compounds (Elgiloy), Nitinol, tungsten, and the like. In embodiments the material comprising the stylus is relatively stiff (as compared to the flexible material of the tube of the GDI), non-corrosive and biocompatible.
Note that the stylus 72-3 can be sufficiently stiff to allow rigidity of the GDI during insertion of the GDI into and through the needle tract. The stylus 72-3 can also be sufficiently short to not restrict the GDI from following the contour of the needle tract. This maneuver is shown in
Note that the length L1 of the stylus 72-3 is configured to be less than the length L1 of the full lumen 5 of the tube 1 of the GDI that extends from the stop surface defined by the distal end 75 of the handle 71. In this configuration, with the proximal end 3 of the tube 1 of the GDI butting up against the stop surface provided by the distal end 75 of the handle 1, the distal end of the stylus 72-3 is displaced from the distal tip of the GDI at a displacement or distance “d” as shown in
In a spring-loaded configuration of the inserter 70-7 shown in
With the inserter 70-7 in its spring-loaded configuration, the user/operator can apply manual forces by hand/finger pressure that pushes the arms 127A and 127B of the actuator 123 radially inward (which is shown by arrows labelled A) and releases the arms 127A, 127B from their engagement with the proximal ends of the corresponding slots 129A, 129B. Such actions can release the actuator 123 and allow the compressed spring 123 to expand whereby the spring forces of the compressed spring 123 move or slide the actuator 123 proximally within the chamber 123 as shown in the spring-released configuration of the inserter 70-7 shown in
As shown in
In embodiments, the stylus of the inserter can be formed from drawn wire where the amount of drawdown determines its hardness. The wire should be sufficiently hard but not too brittle to avoid breaking if bent slightly. Various manufacturing methods can be used to fabricate and assembly the handle and stylus assembly of the inserter. For example, the handle can be injection molded with a hole on the distal end sized to accommodate the stylus. The stylus can be cut to a predetermined length and electropolished. The cut length can be dipped in a UV-cured adhesive, inserted into the hole in the handle and then irradiated with UV light until cured. The GDI can then be mounted on the stylus and the bevel 6 of the GDI oriented to align with the orientation marker on the handle.
In embodiments, the inserter with stylus and the GDI can be packaged as a glaucoma system or kit with the GDI supported by the stylus of the inserter. In this case, the stylus can be located within and received by the lumen 5 of the tube 1 of the GDI as shown in
The inserter configurations and GDI as described herein, with or without a cap (
There have been described and illustrated herein several embodiments of a glaucoma device inserter. While particular embodiments have been described, it is not intended that the invention be limited thereto, as it is intended that the invention be as broad in scope as the art will allow and that the specification be read likewise. It will therefore be appreciated by those skilled in the art that yet other modifications could be made to the provided invention without deviating from its spirit and scope as claimed.
Claims
1. An inserter device for use with a glaucoma drainage device including a tube having a proximal end and a distal end with a lumen extending from the proximal end to the distal end, the inserter device comprising:
- an elongate member having a distal end defining a stop surface; and
- a stylus extending beyond the distal end of the elongate member, wherein the stylus is sized and configured to be received within the lumen of the glaucoma drainage device with the stop surface interfacing to and limiting proximal movement of the glaucoma drainage device, and wherein the stylus has a first length that extends beyond the stop surface that is less than a second length of a portion of the lumen of the tube of the glaucoma drainage device that extends beyond the stop surface.
2. An inserter device according to claim 1, wherein difference between the second length of the lumen of the tube of the glaucoma drainage device and the first length of the stylus is in the range of 0.5 to 3 mm.
3. An inserter device according to claim 1, wherein difference between the second length of the lumen of the tube of the glaucoma drainage device and the first length of the stylus is in the range of 1 to 2 mm.
4. An inserter device according to claim 1, wherein at least part of the stylus is sized and configured to slide within the lumen of the tube of the glaucoma drainage device.
5. An inserter device according to claim 1, further comprising a lubricant that facilitates sliding movement of the stylus within the lumen of the glaucoma drainage device.
6. An inserter device according to claim 1, wherein the stylus has a maximum outer diameter that is 10% to 30% smaller than diameter of the lumen of the tube of the glaucoma drainage device.
7. An inserter device according to claim 1, wherein the diameter of the lumen of the tube of the glaucoma drainage device is in the range of 60 mm to 80 mm, and the stylus has a maximum outer diameter in the range of 42 μm to 72 μm.
8. An inserter device according to claim 1, wherein the stylus is made from a relatively stiff and rigid material, and the tube of the glaucoma drainage device is made from a relatively soft and flexible material.
9. An inserter device according to claim 8, wherein the material of the stylus is selected from the group consisting of stainless steel, cobalt-chromium-nickel compounds (Elgiloy), Nitinol, tungsten, and the like.
10. An inserter device according to claim 8, wherein the material of the tube of the glaucoma drainage device is poly(styrene-block-isobutylene-block-styrene) (SIBS) of Shore hardness less than 60 A.
11. An inserter device according to claim 1, wherein the elongate member includes an orientation marker that is aligned with a bevel on the distal end of the tube of the glaucoma drainage device.
12. An inserter device according to claim 1, wherein the stylus is retractable by operation of inserter device such that the stylus moves proximally relative to the glaucoma drainage device to remove the stylus from the lumen of the tube of the glaucoma drainage device.
13. An inserter device according to claim 1, wherein the stop surface interfaces to the proximal end of the glaucoma drainage device to limit proximal movement of the glaucoma drainage device, and the first length of the stylus is less than full length of the lumen of the tube of the glaucoma drainage device.
14. An inserter device according to claim 1, wherein the elongate member includes an over-tube that is configured to receive and surround a proximal portion of the glaucoma drainage device.
15. An inserter device according to claim 14 for use with the glaucoma drainage device that further includes at least one protrusion that extends radially from the tube of the glaucoma drainage device at an intermediate position between the proximal end and distal end of the tube of the glaucoma drainage device, wherein the over-tube of the inserter device provides the distal end that defines the stop surface, and wherein such stop surface interfaces to the at least one protrusion of the glaucoma drainage device to limit proximal movement of the glaucoma drainage device.
16. A glaucoma system comprising:
- a glaucoma drainage device including a tube having a proximal end and a distal end with a lumen extending from the proximal end to the distal end; and
- an inserter device including an elongate member having a distal end defining a stop surface, and a stylus extending beyond the distal end of the elongate member, wherein the stylus is sized and configured to be received within the lumen of the glaucoma drainage device with the stop surface interfacing to and limiting proximal movement of the glaucoma drainage device, and wherein the stylus has a first length that extends beyond the stop surface that is less than a second length of a portion of the lumen of the tube of the glaucoma drainage device that extends beyond the stop surface.
17. A glaucoma system according to claim 16, wherein difference between the second length of the lumen of the tube of the glaucoma drainage device and the first length of the stylus is in the range of 0.5 to 3 mm.
18. A glaucoma system according to claim 16, wherein difference between the second length of the lumen of the tube of the glaucoma drainage device and the first length of the stylus is in the range of 1 to 2 mm.
19. A glaucoma system according to claim 16, wherein at least part of the stylus is sized and configured to slide within the lumen of the tube of the glaucoma drainage device.
20. A glaucoma system according to claim 16, further comprising a lubricant that facilitates sliding movement of the stylus within the lumen of the glaucoma drainage device.
21. A glaucoma system according to claim 16, wherein the stylus has a maximum outer diameter that is 10% to 30% smaller than diameter of the lumen of the tube of the glaucoma drainage device.
22. A glaucoma system according to claim 16, wherein the diameter of the lumen of the tube of the glaucoma drainage device is in the range of 60 mm to 80 mm, and the stylus has a maximum outer diameter in the range of 42 μm to 72 μm.
23. A glaucoma system according to claim 16, wherein the stylus is made from a relatively stiff and rigid material, and the tube of the glaucoma drainage device is made from a relatively soft and flexible material.
24. A glaucoma system according to claim 23, wherein the material of the stylus is selected from the group consisting of stainless steel, cobalt-chromium-nickel compounds (Elgiloy), Nitinol, tungsten, and the like.
25. A glaucoma system according to claim 23, wherein the material of the tube of the glaucoma drainage device is poly(styrene-block-isobutylene-block-styrene) (SIBS) of Shore hardness less than 60 A.
26. A glaucoma system according to claim 16, wherein the elongate member includes an orientation marker that is aligned with a bevel on the distal end of the tube of the glaucoma drainage device.
27. A glaucoma system according to claim 16, wherein the stylus is retractable by operation of inserter device such that the stylus moves proximally relative to the glaucoma drainage device to remove the stylus from the lumen of the tube of the glaucoma drainage device.
28. A glaucoma system according to claim 16, wherein the stop surface interfaces to the proximal end of the glaucoma drainage device to limit proximal movement of the glaucoma drainage device, and the first length of the stylus is less than full length of the lumen of the tube of the glaucoma drainage device.
29. A glaucoma system according to claim 16, where the elongate member of the inserter device comprises an over-tube that is configured to receive and surround a proximal portion of the glaucoma drainage device.
30. A glaucoma system according to claim 29, wherein the glaucoma drainage device further comprises at least one protrusion that extends radially from the tube of the glaucoma drainage device at an intermediate position between the proximal end and distal end of the tube of the glaucoma drainage device, wherein the over-tube provides the distal end that defines the stop surface, and wherein such stop surface interfaces to the at least one protrusion of the glaucoma drainage device to limit proximal movement of the glaucoma drainage device.
31. A method of implanting a glaucoma drainage device in an eye comprising:
- forming a tissue passageway under the limbus to the anterior chamber of the eye;
- inserting a glaucoma drainage device, supported and carried on a stylus of an inserter device, into and through the tissue passageway so that a distal end of the glaucoma drainage device is disposed in the anterior chamber; and
- retracting the stylus from glaucoma drainage device leaving the glaucoma drainage device behind in the tissue passageway.
32. The method according to claim 31, wherein:
- the glaucoma drainage device includes a tube having a proximal end and the distal end with a lumen extending from the proximal end to the distal end, and
- the inserter device includes an elongate member having a distal end defining a stop surface, and a stylus extending beyond the distal end of the elongate member, wherein the stylus is received within the lumen of the glaucoma drainage device with the stop surface interfacing to and limiting proximal movement of the glaucoma drainage device, and wherein the stylus has a first length that extends beyond the stop surface that is less than a second length of a portion of the lumen of the tube of the glaucoma drainage device that extends beyond the stop surface.
33. The method according to claim 32, further comprising:
- forming a pocket in the sclera to house projections that extend radially from an exterior surface of the tube of the glaucoma drainage device at an intermediate position between the distal and proximal ends of the glaucoma drainage device.
34. The method according to claim 32, wherein:
- retracting the stylus includes actuating a slide mechanism of the inserter configured to retract the stylus proximally relative to the stop surface.
Type: Application
Filed: Feb 20, 2020
Publication Date: May 5, 2022
Applicant: INNFOCUS, INC. (Miami, FL)
Inventor: Leonard PINCHUK (Miami, FL)
Application Number: 17/433,907